Data / Medical devices / Ldl & Vldl Precipitation, Hdl / United States
FDA-registered makers of Ldl & Vldl Precipitation, Hdl in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Ldl & Vldl Precipitation, Hdl (product code LBR). 7 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Ldl & Vldl Precipitation, Hdl
- Product code
- LBR
- Country
- United States
Makers of Ldl & Vldl Precipitation, Hdl in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 3 | August 5, 1999 | 0 | 4 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 2 | July 26, 2005 | 0 | 0 | 0 | api.fda.gov |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer, Manufacturer for export | 1 | August 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | March 21, 1983 | 0 | 0 | 0 | api.fda.gov |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 1 | January 22, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | August 30, 2001 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | August 30, 2001 | 0 | 0 | 0 | api.fda.gov |
| Acon Laboratories, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| East West Wisconsin | Whitewater, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osang LLC | S Pasadena, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymer Technology Systems | Whitestown, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.